Monday, February 11, 2013

Could Johnson & Johnson Recall the DePuy Pinnacle Hip ImplantAnd How Could this Affect You?

A Brief Overview of the DePuy Hip Implant

The DePuy Pinnacle metal hip implant is the same monoblock type of implant as DePuy’s ASR however has a few key differences. Of course the primary difference is that the ASR was recalled in 2010 while the Pinnacle is still on the market. Because of the recall of the ASR—which gained FDA approval based on being substantially equivalent to the Pinnacle—there are serious concerns regarding the Pinnacle as well. The Pinnacle received FDA approval in 2000, howevermany orthopedic experts believe that not only does the Pinnacle suffer from a defective design; it also has a propensity for early failure rates and metal toxicity.

The primary problem with the Pinnacle hip implant—as well as most all the metal-on-metal implants—is that by its very design when the implant recipient engages in activity, the metal components rub against one another causing small shards of cobalt and chromium to shear away into the body. These metal ions, though they are microscopically tiny, can lodge into the surrounding tissues or enter the bloodstream. The Pinnacle design implemented a ceramic head, however a metal liner was used in many patients, resulting in the same metal-on-metal friction.

What Led to the Johnson & Johnson DePuy ASR Hip Recall?

Johnson & Johnson, the parent company of DePuy Orthotics received adverse reports regarding the ASR failure rate a full two years before the hip implant recall was issued. Johnson & Johnson stated the determination to recall the products stemmed from the number of implant recipients who had required subsequent hip implant surgeries after their ASR failed. At the time of the ASR recall, the FDA notified DePuy and J & J that their Pinnacle hip implant model was being used with a metal liner which had not been through FDA approval.

At least 93,000 ASR hip implants were implanted across the globe prior to the recall and J & J and DePuy maintained—evenin the face of the recall—that the majority of the ASR hip implant devices were successful. They did, however, advise patients who received an ASR implant to visit their physician for annual monitoring. It is estimated that 12-13 percent of ASR patients will require a surgical revision within sixty months of the first implant, and it is believed that Pinnacle rates are similar. The revision surgery for the Pinnacle is much simpler; the metal liner is replaced with a polyethylene liner rather than having to replace the entire hip implant.

The Seriousness of MetallosisSymtpoms

When the cobalt and chromium ions enter the bloodstream, there is the potential for a wide variety of medical problems for the implant recipient. Cardiovascular, neurological, renal and thyroid issues have been reported as well as loss of hearing and vision, gastrointestinal disorders, alteration of DNA, the development of cancer in some instances, the growth of pseudo-tumors, memory loss, vertigo, skin problems, and numbness or tingling in the extremities. Any person with a metal hip implant should have regular blood testing done to determine the levels of cobalt and chromium in the body.

When it’s Time to Consider if You Have a DePuy Pinnacle Hip Implant Case

Both the Pinnacle and the ASR have already suffered their share of lawsuits, both MDL, class action and individual. There are statutes of limitations involved in these lawsuits, so it is important not to wait until your window of opportunity has passed. vision loss, skin disorders and gastrointestinal problems are all seen in those with higher-than-normal levels of metals in their body. In some people large cysts known as pseudo-tumors can occur as the cobalt and chromium levels build up.

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